| UltraFlex IAB (K190101) | Arrow International, Inc. | 2019-06-28 |
| ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K191175) | Acist Medical Systems, Inc. | 2019-06-27 |
| Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K190785) | Innovative Health, LLC | 2019-06-25 |
| Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (K191207) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-06-25 |
| Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (K190106) | Centerline Biomedical, Inc. | 2019-06-24 |
| Oscillometric Blood Pressure Monitor (K190927) | Rudolf Riester GmbH | 2019-06-24 |
| ASAHI SASUKE (K182844) | Asahi Intecc Co., Ltd. | 2019-06-22 |
| The ClearSight finger cuffs (K190130) | Edwards Lifesciences, LLC | 2019-06-21 |
| FloPatch (FP110) (K191388) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019-06-21 |
| Aneroid Type Blood Pressure Kit (K191209) | Dongguan Mars Medical Products Co., Ltd. | 2019-06-18 |
| Torpedo Gelatin Foam (K183578) | Biosphere Medical, S.A. | 2019-06-18 |
| FlowTriever Retrieval/Aspiration System (K191368) | Inari Medical | 2019-06-17 |
| Penumbra System Reperfusion Catheter JET 7 (K190010) | Penumbra, Inc. | 2019-06-16 |
| VIVO (K183195) | Catheter Precision, Inc. | 2019-06-14 |
| Edwards Pressure Cable (K191089) | Edwards Lifesciences, LLC | 2019-06-13 |
| Fiberoptix IAB (K190117) | Arrow International, Inc. | 2019-06-13 |
| Full Automatic (NIBP) Blood Pressure Monitor-HL158UB (K190133) | Health & Life Co., Ltd. | 2019-06-13 |
| Life Sensor Cardiac Monitor (K191331) | Braveheart Wireless, Inc. | 2019-06-12 |
| Scoreflex PTA Scoring Balloon Catheter (K182713) | Orbusneich Medical Trading, Inc. | 2019-06-11 |
| Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable (K183649) | Baylis Medical Company, Inc. | 2019-06-07 |
| VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 (K190916) | Vitalconnect, Inc. | 2019-06-07 |
| Masimo O3 Regional Oximeter System (K182429) | Masimo Corporation | 2019-06-07 |
| Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable (K183632) | Baylis Medical Company, Inc. | 2019-06-07 |
| Fully Automatic Electronic Blood Pressure Monitor (K183535) | Andon Health Co, Ltd. | 2019-06-04 |
| Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors (K182503) | Physio-Control, Inc. | 2019-06-03 |
| GaltTWS (K182660) | Galt Medical Corp. | 2019-05-30 |
| FlexSeal Introducer Sheath with Hydrophilic Coating (K190628) | Freudenberg Medical Mis, Inc. | 2019-05-30 |
| MitraClip G4 Steerable Guide Catheter (K190167) | Abbott | 2019-05-29 |
| Nihon Kohden SVM-7200 Series Vital Signs Monitor (K190468) | Nihon Kohden Corporation | 2019-05-28 |
| Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (K190282) | Spectrum Medical , Ltd. | 2019-05-24 |
| IMPEDE-FX Embolization Plug (K182390) | Shape Memory Medical | 2019-05-23 |
| Upstream GoBack Crossing Catheter (K182937) | Upstream Peripheral Technologies, Ltd. | 2019-05-23 |
| RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope (K190902) | Wenzhou Renhua Instruments Co., Ltd. | 2019-05-22 |
| Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure (K183646) | Edwards Lifeciences, LLC | 2019-05-21 |
| Full Automatic (NIBP) Blood Pressure Monitor-HL158TB (K190134) | Health & Life Co., Ltd. | 2019-05-20 |
| VersaCross Transseptal Sheath (K183655) | Baylis Medical Company, Inc. | 2019-05-20 |
| CardioGard Emboli Protection Cannula (K182302) | Cardiogard Medical, Ltd. | 2019-05-17 |
| Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac (K191029) | Medtronic, Inc. | 2019-05-17 |
| Carnation Ambulatory Monitor (K191000) | Bardy Diagnostics, Inc. | 2019-05-16 |
| Tel-O-Graph (K173895) | I.E.M. Industrielle Entwicklung and Medizintechnik | 2019-05-16 |
| Fully Automatic Electronic Blood Pressure Monitor (K183534) | Andon Health Co, Ltd. | 2019-05-16 |
| Masimo Rad-97 and Accessories (K183697) | Masimo Corporation | 2019-05-15 |
| SOFIA EX Intracranial Support Catheter (K182602) | MicroVention, Inc. | 2019-05-15 |
| SpO2 Sensor (K183277) | Shenzhen Upnmed Equipment Co., Ltd. | 2019-05-15 |
| Liba3 System (K182532) | National Cardiac, Inc. | 2019-05-15 |
| D'Vill Introducer (K190974) | NuMED, Inc. | 2019-05-14 |
| Triangle System (K183319) | AliveCor, Inc. | 2019-05-10 |
| TOF-Cuff monitor (K181894) | Rgb Medical Devices SA | 2019-05-09 |
| Wingman 14C Crossing Catheter (K190393) | Reflow Medical, Inc. | 2019-05-09 |
| Reprocessed ViewFlex Xtra ICE Catheter (K182238) | Stryker Sustainability Solutions | 2019-05-08 |
| BioCardia 8.5 F Avance Steerable lntroducer (K190941) | Biocardia, Inc. | 2019-05-06 |
| SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface (K190560) | Nonin Medical, Inc. | 2019-05-02 |
| Cocoon Convective Warming System (K181671) | Care Essentials Pty, Ltd. | 2019-05-02 |
| Synchro2 Support Guidewire (K190843) | Stryker | 2019-05-01 |
| TruWave Disposable Pressure Transducer (K183413) | Edwards Lifeciences, LLC | 2019-05-01 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K190825) | Medtronic, Inc. | 2019-04-30 |
| Eclipse 2L (K183045) | Balt USA, LLC | 2019-04-30 |
| Aspiron(TM) Aspiration Catheter (K190619) | Meril Life Sciences Private Limited | 2019-04-29 |
| Philips IntelliVue XDS Software (K182637) | Philips Medizin Systeme Boeblingen GmbH | 2019-04-26 |
| Penumbra System 3D Revascularization Device (K190464) | Penumbra, Inc. | 2019-04-26 |
| Multi-Sideport Catheter Infusion Set (K182071) | Cook Incorporated | 2019-04-25 |
| A&D Medical Blood Pressure Monitors (K173065) | A&D Company, Ltd. | 2019-04-24 |
| Occlusion Balloon Catheter (K183679) | Qxmedical, LLC | 2019-04-24 |
| AXS Vecta Aspiration System (K190212) | Stryker Neurovascular | 2019-04-24 |
| Reprocessed Supreme Diagnostic Electrophysiology Catheter (K182386) | Innovative Health, LLC | 2019-04-23 |
| EverCrossTM 0.035 OTW PTA Dilatation Catheter (K190753) | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) | 2019-04-23 |
| exGraft, exGraft Carbon (K183613) | Peca Labs | 2019-04-22 |
| Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J (K182457) | Brivant Limited (Lake Region Medical) | 2019-04-18 |
| NeoForm Annuloplasty Ring (K190506) | Genesee Biomedical, Inc. | 2019-04-18 |
| Guide Sheath (K190644) | Surmodics,Inc. | 2019-04-18 |
| 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter (K183043) | Imperative Care, Inc. | 2019-04-17 |
| JETi 88 Peripheral Thrombectomy System (K183403) | Walk Vascular, LLC | 2019-04-17 |
| HEM-6410T-ZL Wrist Blood Pressure Monitor (K190693) | Omron Healthcare, Inc. | 2019-04-17 |
| eMurmur ID (K181988) | Csd Labs GmbH | 2019-04-17 |
| VersaCross Steerable Sheath, VersaCross Transseptal Dilator (K190688) | Baylis Medical Company, Inc. | 2019-04-17 |
| SmartLinx Vitals Plus Patient Monitoring System (K183638) | Capsule Technologie | 2019-04-17 |
| M-Y Sheath (K190369) | Ram Medical Innovations, Inc. | 2019-04-17 |
| Dr. Amplatz Micro Plug (K182944) | Ka Medical, LLC | 2019-04-17 |
| Stasis Monitoring System (K183634) | Stasis Labs, Inc. | 2019-04-17 |
| Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK (K181541) | Andon Health Co, Ltd. | 2019-04-16 |
| INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir (K190690) | Sorin Group Italia S.R.L. | 2019-04-13 |
| KardiaMobile, KardiaStation (K182396) | AliveCor, Inc. | 2019-04-12 |
| Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface (K183490) | Medtronic, Inc. | 2019-04-12 |
| Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (K183599) | Infraredx, Inc. | 2019-04-12 |
| S-MAK XL (K190175) | Merit Medical Systems, Inc. | 2019-04-10 |
| Confirm Rx Insertable Cardiac Monitor (K190295) | Abbott (St. Jude Medical) | 2019-04-10 |
| Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device (K181832) | Guangdong Transtek Medical Electronics Co., Ltd. | 2019-04-09 |
| Pantheris SV (K182341) | Avinger, Inc. | 2019-04-09 |
| Patient Monitor (K181919) | Guangdong Biolight Meditech Co., Ltd. | 2019-04-05 |
| Amplatzer Trevisio Intravascular Delivery System (K190581) | ABBOTT MEDICAL | 2019-04-05 |
| EkoSonic Endovascular Device with Control Unit 4.0 (K183361) | Btg International, Inc. | 2019-04-05 |
| Park Blade Septostomy Catheter (K182399) | Cook Incorporated | 2019-04-04 |
| GMC Upper Arm Automatic Blood Pressure Monitor (K181931) | Gmc, Inc. | 2019-04-04 |
| Bio-Medicus Insertion Kit (K190557) | Medtronic, Inc. | 2019-04-03 |
| AcQMap High Resolution Imaging and Mapping System (K190131) | Acutus Medical, Inc. | 2019-04-02 |
| Loop System (K181352) | Spry Health, Inc. | 2019-03-29 |
| 3880 MRI Patient Monitoring System (K180903) | Iradimed Corporation | 2019-03-29 |
| Confirm Rx Insertable Cardiac Monitor (K182981) | Abbott | 2019-03-29 |
| eKuore One electronic interface for stethoscope (K181882) | Chip Ideas Electronics S.L. | 2019-03-27 |
| WOLF Thrombectomy Device (K182835) | 880 Medical, LLC | 2019-03-27 |